Summary

Eligibility
for people ages 21-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Ziva D Cooper, PhD (ucla)

Description

Summary

This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.

Official Title

Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol

Details

The overall aim of this double-blind, placebo-controlled, within-subject study in healthy, occasional cannabis smokers is to ascertain the dose-dependent analgesic and appetite-stimulating effects of ecologically relevant doses of cannabigerol (CBG) alone and in combination with a sub-analgesic / sub-appetite stimulating, minimally psychoactive dose of THC and an analgesic, appetite-stimulating, but intoxicating dose of THC.

Keywords

Pain, Appetite Loss, Abuse, Drug, Analgesia, Appetite, THC, Cannabigerol, CBG, Substance-Related Disorders, Dronabinol, Low CBG, High CBG, Low THC, High THC, Low strength CBG, High strength CBG, Low strength THC, High strength THC, Low strength CBG + Low strength THC, Low strength CBG + High strength THC, High strength CBG + Low strength THC, High strength CBG + High strength THC

Eligibility

You can join if…

Open to people ages 21-55

  • Male or non-pregnant and non-lactating females aged 21-55 years
  • • Report occasional use of cannabis (cannabis use between ≥ biweekly and ≤ 3 days per week) over the month prior to screening
  • Not currently seeking treatment for their cannabis use
  • Have a Body Mass Index from 18.5 - 34kg/m2.
  • Able to perform all study procedures
  • Must be using a contraceptive (hormonal or barrier methods)
  • Females must not be lactating

You CAN'T join if...

  • Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, or mild CUD
  • Any other Axis I disorder
  • • Current use of any medications within 14 days or 5 half-lives of administration (whichever is longer) except for hormonal contraceptives in females. If a medication is taken once a participant is enrolled, sessions will be suspended for 14 days or 5 half-lives after administration (whichever is longer)
  • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
  • Current pain
  • Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
  • History of an allergic reaction or adverse reaction to cannabis is exclusionary.
  • History of respiratory illness or current respiratory illness
  • Currently enrolled in another research protocol
  • Not using a contraceptive method (hormonal or barrier methods)
  • Insensitivity to the cold water stimulus of the Cold Pressor Test
  • Any disorders that might make cannabis administration hazardous are exclusionary, as determined by the evaluating physician

Location

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Ziva D Cooper, PhD (ucla)
    Associate Professor-in-Residence, Psychiatry and Biobehavioral Sciences, Medicine. Authored (or co-authored) 69 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04859296
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated